CH505w53 for Human Immunodeficiency Virus (HIV) Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Human Immunodeficiency Virus (HIV) InfectionCH505w53 - Biological
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new HIV vaccine to see if it is safe and if it causes an immune response in healthy people who do not have HIV.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

11 Primary · 9 Secondary · Reporting Duration: Measured through Month 28

Measured through Month 24
Part A: Frequency of HIV-specific binding Ab responses
Part A: Frequency of adverse events (AEs)
Part A: Frequency of local reactogenicity signs and symptoms
Part A: Frequency of severe adverse events (SAEs)
Part A: Frequency of systemic reactogenicity signs and symptoms
Part A: Magnitude of differential binding to CH505 gp120 compared to CH505 I delta 371 protein
Part A: Magnitude of neutralizing antibody responses
Part A: Magnitude of neutralizing antibody responses against autologous viral isolates
Part A: Monoclonal antibody binding and neutralization response rates
Part A: Response rate of CD4+ T-cell responses
Measured through Month 28
Part B: Frequency of AEs
Part B: Frequency of HIV-specific binding antibody (Ab) responses
Part B: Frequency of SAEs
Part B: Frequency of local reactogenicity signs and symptoms
Part B: Frequency of systemic reactogenicity signs and symptoms
Part B: Magnitude of neutralizing antibody response
Antibodies, Blocking
Part B: Monoclonal antibody binding response rates
Part B: Monoclonal antibody neutralization response rates
Part B: Response rate of CD4+ T-cell responses

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

8 Treatment Groups

Part A: Group 2
1 of 8
Part A: Group 1
1 of 8
Part B: Group 5
1 of 8
Part A: Group 3
1 of 8
Part B: Group 6
1 of 8
Part B: Group 7
1 of 8
Part A: Group 4
1 of 8
Part B: Group 8
1 of 8

Experimental Treatment

Non-Treatment Group

107 Total Participants · 8 Treatment Groups

Primary Treatment: CH505w53 · Has Placebo Group · Phase 1

Part A: Group 2Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part A: Group 1Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part B: Group 5Experimental Group · 4 Interventions: CH505w53, CH505TF, CH505w78, GLA-SE adjuvant · Intervention Types: Biological, Biological, Biological, Biological
Part A: Group 3Experimental Group · 2 Interventions: CH505TF, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part B: Group 6Experimental Group · 4 Interventions: CH505w53, CH505TF, CH505w78, GLA-SE adjuvant · Intervention Types: Biological, Biological, Biological, Biological
Part B: Group 7Experimental Group · 2 Interventions: CH505 M5, GLA-SE adjuvant · Intervention Types: Biological, Biological
Part A: Group 4
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Part B: Group 8
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLA-SE adjuvant
2018
Completed Phase 1
~60

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured through month 28

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,153 Previous Clinical Trials
4,770,856 Total Patients Enrolled
James KobieStudy ChairUniversity of Alabama at Birmingham
Magda SobieszczykStudy ChairColumbia University

Eligibility Criteria

Age 18 - 50 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have good general health as shown by medical history, physical exam, and screening laboratory tests.
You are willing to be followed for the planned duration of the study.
You are willing to discuss HIV infection risks and amenable to HIV risk reduction counseling.